30 APRIL 2019
San Mateo, California, United States, and Hangzhou and Shaoxing, China, 30 April 2019
3-V Biosciences, Inc. (3-V Biosciences) and Ascletis Pharma Inc. (Ascletis, 1672.HK) announced today that 3-V Biosciences has recently dosed its first patient in a Phase 2 clinical trial of the FASN (fatty acid synthase) inhibitor TVB-2640 (Ascletis code: ASC40) in patients with non-alcoholic steatohepatitis (NASH).
According to Rohit Loomba, MD, University of California San Diego, Director, NAFLD Research Center, and Coordinating Investigator of the now enrolling Phase 2 study of TVB-2640, “Lipid synthesis is an important driver of NASH. The imaging techniques in this study will give us a very clear understanding of the impact this drug has on liver fat, a key driver of this disease.”
In this randomized, placebo-controlled study, investigators will evaluate the impact of TVB-2640 in about 90 NASH patients in the United States and about 25-30 NASH patients in China. Study participants will have at least 8% liver fat at baseline, as measured by magnetic resonance imaging-estimated proton density fat fraction (MRI-PDFF), and evidence of stage F1 to F3 fibrosis. The primary endpoint is the impact of TVB-2640 on liver fat reduction, compared to baseline, following 12 weeks of daily, continuous dosing. Investigators will also evaluate TVB-2640’s impact on levels of plasma triglycerides, liver enzymes, inflammatory and fibrotic biomarkers.
In February 2019, 3-V Biosciences and Ascletis entered into an exclusive license agreement, under which 3-V Biosciences granted Ascletis an exclusive license to develop, manufacture and commercialize TVB-2640 (Ascletis code: ASC40) and related compounds in Greater China. In connection with this Phase 2 trial, Ascletis is working with 3-V Biosciences in China on regulatory submissions, clinical site selection, and trial monitoring.
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